• Title/Summary/Keyword: Healthy volunteers

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1H NMR metabolomics study for diabetic neuropathy and diabetes

  • Hyun, Ja-Shil;Yang, Jiwon;Kim, Hyun-Hwi;Lee, Yeong-Bae;Park, Sung Jean
    • Journal of the Korean Magnetic Resonance Society
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    • v.22 no.4
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    • pp.149-157
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    • 2018
  • Diabetes is known to be one of common causes for several types of peripheral nerve damage. Diabetic neuropathy (DN) is a significant complication lowering the quality of life that can be frequently found in diabetes patients. In this study, the metabolomic characteristic of DN and Diabetes was investigated with NMR spectroscopy. The sera samples were collected from DN patients, Diabetes patients, and healthy volunteers. Based on the pair-wise comparison, three metabolites were found to be noticeable: glucose, obviously, was upregulated both in DN patients (DNP) and Diabetes. Citrate is also increased in both diseases. However, the dietary nutrient and biosynthesized metabolite from glucose, ascorbate, was elevated only in DNP, compared to healthy control. The multivariate model of OPLS-DA clearly showed the group separation between healthy control-DNP and healthy control-Diabetes. The most significant metabolites that contributed the group separation included glucose, citrate, ascorbate, and lactate. Lactate did not show the statistical significance of change in t-test while it tends to down-regulated both in DNP and Diabetes. We also conducted the ROC curve analysis to make a multivariate model for discrimination of healthy control and diseases with the identified three metabolites. As a result, the discrimination model between healthy control and DNP (or Diabetes) was successful while the model between DNP and Diabetes was not satisfactory for discrimination. In addition, multiple combinations of lactate and citrate in the OPLS-DA model of healthy control and diabetes group (DNP + Diabetes patients) gave good ROC value of 0.952, which imply these two metabolites could be used for diagnosis of Diabetes without glucose information.

Analysis of Copper, Zinc in Serum Using ICP-MS & AAS (ICP-MS와 AAS를 이용한 체내 혈청 Cu, Zn 분석에 관한 연구)

  • Lee, Yea-Jin;Kim, Dong-Yub;Lee, Go-Eun;Jo, Young-Suk
    • Korean Journal of Clinical Laboratory Science
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    • v.41 no.1
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    • pp.31-36
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    • 2009
  • The exposure of human beings to toxic trace metals (Cu, Zn) continues to be an important public health issue and concern. This study was conducted to assess the exposure to trace metals (Cu, Zn) in the general Korean population by inductively coupled plasma mass spectrometry (ICP-MS) and Atomic absorption spectrometry (AAS). Serum samples were obtained from 40 healthy volunteers. Specimens were collected in special container and we applied sample processing to minimize contamination. We used ICP-MS and AAS to analyze simultaneously the concentration of metals including copper, zinc. Distribution of trace metal levels in the general healthy population showed lower values. The results in this study can provide background data for clinical studies associated with trace metal exposure in the korean population.

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Effects of Vitamin C Supplementation on Immune Status in Smoking and Nonsmoking Male College Students (흡연자에 있어 비타민 C 보충이 면역능력에 미치는 영향)

  • 김우경
    • Journal of Nutrition and Health
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    • v.31 no.8
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    • pp.1244-1253
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    • 1998
  • This study investigated the effects of vitamin C supplementation on immune status in smoking and nonsmoking male college students. Blood samples were obtained from 15 healthy smoking and from 15 healthy nonsmoking volunteers before and 4 weeks after vitamin C supplementation (1000mg/day). Daily nutrient intakes was also calculated. Plasma vitamin C, E, and A concentrations, white blood cells and subpopulations, lymphocytes and subpopulations, NK cell percentage,plasma immunoglobulin A, G, M and complement C3, plasma interleukin-2 , and prostagladin E2 were measured . Daily vitamin C consumption was lower in smokers than in nonsmokers. Vitamin C supplementation significantly increased plasma vitamin C in smokers, and increased NK cell percentage in smokers and nonsmokers. Plasma IL-2 concentrations were significantly increased by vitamin C supplementation in nonsmokers, and decreased helpe $r^pressor T cell ratio were decreased by vitamin C supplementatiion , but the differences were not significant. White blood cells and subpopulation percentage and plasma prostaglandin E2 concentration were not affected by smoking and vitamin C supplementation. These findings as nonsmokers.rs.

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Elderly Residents' Behavior Problems as Experienced by Volunteers Working in Low-Income Welfare Facilities (자원봉사자가 경험한 저소득층 복지시설 거주노인의 문제행동)

  • Lee, In-Soo
    • Journal of Families and Better Life
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    • v.25 no.1 s.85
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    • pp.127-144
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    • 2007
  • This study was conducted for the purpose of analyzing volunteer workers' perceptions of and attitudes toward the behavior problems of the elderly residents after caring for the residents voluntarily at low-income nursing homes. Eleven male and female volunteers ranging from age 19 to 52 were asked how they felt about the elderly residents' behavior problems and what kind of behavioral problems they had experienced after doing volunteer works in the three chosen facilities. In particular, they were expected to explain what emotional changes they experienced during their volunteer service. In this study, it was observed that most of the elderly subjects experienced three categories of behavior problems: habitual, repetitious and unreasonable activities caused by the elderly residents' life span backgrounds, unexpected and/or abrupt behaviors resulting from gradual cognitive impairments, and physiological, awkward activities caused from gradual senility. The volunteers tend to believe that the elderly residents are naturally expected to act positively, since they have been provided with well- planned, regular care services such as bathing, counseling, activity programs, and religious guidances. On the other hand, some respondents stated that their experiences at the nursing homes caused them to form negative images of the elderly; they feel that the elderly are not helpful for giving advices on critical decisions, guiding and encouraging their daily lives, and offering any positive influences toward their own lives. Rather, they find themselves getting too much stressed as a result of their intimate contacts with demented or senile residents. Overall, in this study, it is proposed that education for confronting sudden abrupt behavior problems should be intensified more for female volunteers, since they tend to be more susceptible to emotional harassment resulting from the problem behaviors. It is also proposed that young volunteers who have not been systematically trained for confronting aggressive behaviors need to be separately assigned their roles in order to minimize the potential of confronting unseemly situations resulting from male residents whose mental health has deteriorated. Furthermore, it is also suggested that the combination of leisure-related activities for healthy residents and stressful intimate services for the frail residents be systematically planned and implanted for the volunteer program so that the volunteers can lessen the chances of suddenly finding themselves confronted with extremely abrupt agitations.

Dose- and Time-Related Effects of Pilocarpine Mouthwash on Salivation

  • Song, Je-Il;Park, Jo-Eun;Kim, Hye-Kyoung;Kim, Mee-Eun;Kim, Ki-Suk
    • Journal of Oral Medicine and Pain
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    • v.42 no.3
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    • pp.72-80
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    • 2017
  • Purpose: Pilocarpine as a salivation stimulant in pill form has mostly been used to relieve oral dryness for xerostomic patients but its use may often be limited due to variable side effects from systemic absorption. Therefore, the purpose of this study was to investigate the effects of pilocarpine mouthwash on salivation according to the variable concentration and duration for healthy volunteers. Related adverse effects and subjective assessment on its effects on salivation were also examined. Methods: This study was performed as placebo-controlled, double-blind, randomized clinical trial. Thirty healthy volunteers (male=23, mean age=22.2 years) were randomly allocated to 6 groups with the different concentration of pilocarpine mouthwash (placebo, 0.1%, 0.5%, 1.0%, 1.5%, and 2.0%). The whole experiment consisted of 3 sessions according to the duration of mouthwash, i.e., 1, 3, and 5 minutes with the mean wash-out period ${\geq}2$ days between the sessions. Unstimulated whole saliva was collected before and after gargling with a mouthwash. Results: Salivation of the higher concentration groups ${\geq}1%$ significantly increased than those of lower concentration group. The application period of mouthwash did not cause any changes of salivary flow rate at the higher concentrations ${\geq}1.0%$. The lower concentrations of 0.5% and 0.1% had no effects on salivation even after 5-minute mouthwash. There was no significant difference between blood pressure and pulse rate before and after use of mouthwash. Conclusions: From the results of the current study, pilocarpine mouthwash with at least 1.0% concentration more than a minute might be clinically effective in salivation without any serious side effects. Dose of mouthwash rather than duration seems to be a critical factor to salivation.

Determination of Hydrochlorothiazide in Human Plasma by HPLC and Applicability to Oral Bioavailability in Korean Healthy Male Volunteers (HPLC를 이용한 혈중 히드로클로로티아지드의 분석 및 이를 이용한 한국인 성인남성에 대한 생체이용률 평가)

  • Park, Ah-Yeon;Kim, Jin-Hee;Kim, Sung-Yong;Chi, Sang-Cheol;Bok, Hae-Sook;Kim, Ho-Jung;Youm, Jeong-Rok;Han, Sang-Beom
    • YAKHAK HOEJI
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    • v.50 no.5
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    • pp.301-307
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    • 2006
  • A simple and sensitive high-performance liquid chromatographic method for quantitation of hydrochlorothiazide in human plasma was developed and bioavailability parameters of hydrochlorothiazide were assessed in Korean healthy male volunteers. Caffeine was used as an internal standard. Hydrochlorothiazide and internal standard in plasma sample were extracted using tert-butylmethylether (TBME). A centrifuged upper layer was then evaporated and reconstituted with mobile phase of acetonitrile-25 mM phosphate buffer (20/80, pH 2.5). The reconstituted samples were injected into a Luna C18 column $(250{\times}4.6\;mm,\;5{\mu}m)$ at a flow-rate of 1.0 ml/min. The wavelength was set at 230 nm and no endogenous substances were found to interfere, A linear relationship for hydrochlorothiazide was found in the range of $10{\sim}300\;ng/ml$. The lower limit of quantitation (LLOQ) was 10 ng/ml with acceptable precision and accuracy. Assayed in plasma, the intra- and inter-day validation for all coefficients of variation (R.S.D.%) were found less than 15%. Main pharmacokinetic parameters of 50mg of hydrochlorothiazide were revealed as follows: $AUC_t\;1761{\pm}509.0\;ng{\cdot} hr\;ml,\;C_{max}\;296.5{\pm}95.5\;ng/ml,\;T_{max}\;1.94{\pm}0.85hr,\;K_{el}\;0.12{\pm}0.04\;hr^{-1}\;and T_{12}\;6.81{\pm}2.92\;hr.\;C_{max}\;and\;T_{max}$ were in accordance with the values $(270{\sim}350\;ng/ml\;and\;1.9{\sim}2.7\;hr)$ of Caucasian.

Bioequivalence of Cefaclor Capsules Following Single Dose Administration to Healthy Male Volunteers (세파클러 캅셀제에 대한 생물학적 동등성 평가)

  • Bok, Hae Sook;Kim, Myoung Min;Kwon, Yi Oh;Choi, Kyung Eob
    • Korean Journal of Clinical Pharmacy
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    • v.7 no.1
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    • pp.17-21
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    • 1997
  • Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with $Ceclor^{TM}$ introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours $(AUC_{0-4h})$ was calculated by the trapezoidal summation method. The differences in mean values of $AUC_{0-4h}$, peak plasma concentration $(C_{max})$, and time to peak concentration $(T_{max})$ between the two products were $4.63\%,\;1.84\%,\;and\3.28\%$, respectively. The least significant differences at $\alpha4= 0.05 for $AUC_{0-4h},\;C_{max},\;and\;T_{max}\;were\;6,53\%,\;4.05\%,\;and\;6.47\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

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Oral Bioavailability of Levosulpiride in Korean Healthy Male Volunteers (건강한 한국인 성인 남성에서 레보설피리드 제제의 생체이용률)

  • Lee, Jung-Min;Choi, Sung-Up;Kim, Hee-Kyu;Yoon, Mi-Kyeong;Kim, Se-Hee;Youm, Jeong-Rok;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.33 no.3
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    • pp.201-208
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    • 2003
  • Pharmacokinetics and oral bioavailability of levosulpiride was determined in Korean healthy male volunteers. Thirty subjects received a single oral dose (25 mg) of a tablet in a randomized $2{\times}2$ cross-over design. The plasma concentrations of levosulpiride were measured by HPLC and compared with those reported in the literature. Pharmacokinetic parameters for $Isomeric^{\circledR}$ tablet (levosulpiride 25 mg) were revealed as follows: $AUC_{inf}\;737.1{\pm}176.9\;ng{\cdot}hr/ml,\;C_{max}\;56.4{\pm}20.1\;ng/ml,\;T_{max}\;4.2{\pm}1.6\;hr,\;K_a\;1.00{\pm}1.09\;hr^{-1},\;K_{el}\;0.08{\pm}0.02\;hr^{-1},\;and\;t_{1/2}\;8.8{\pm}1.9\;hr$. The rate constant of the absorption phase was obtained based on the first-order kinetics. In the aspect of bioavailability, $Isomeric^{\circledR}$ tablet was bioequivalent to the other product $(Levopride^{\circledR}\;tablet)$ available in the Korea market. Intersubject variations and race differences were show in comparison with the published data in the literature, even though there was a linear relationship between dose ad extent of bioavailability.

Measurement of Normal Gastric Emptying Rate Using Chicken Liver Labeled with $^{99m}Tc-Colloid$ (정상인의 Gastric Emptying Rate 측정)

  • Lee, Cheorl-Woo;Kim, Chahng-Guhn;Kim, Byung-Chan;Won, Jong-Jin;Nah, Yong-Ho
    • The Korean Journal of Nuclear Medicine
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    • v.22 no.2
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    • pp.193-197
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    • 1988
  • Measurement of gastric emptying rate has been performed by a variety of techniques. Nuclear medicine method is a major advance in the quantitative evaluation of gastric function and also of pharmacologic intervention. Normal gastric emptying rate was measured in 48 healthy volunteers using live chicken liver labeled with $^{99m}Tc-Tin$ Colloid as a solid phase marker. In vitro studies were performed to evaluate the labeling efficiency and stability in hydrochloric acid and in human gastric juice of intracellularly labeled chicken liver. Anterior image counts only were compared with the geometric mean of anterior and posterior counts in 12 healthy volunteers who were studied by both anterior count and posterior count. The results were as follows: 1) The labeling efficiency in gastric juice and hydrochloric acid were $95.5{\pm}1.23%,\;95.7{\pm}1.15%$, respectively. 2) Half gastric emptying time by anterior count only was $126{\pm}21$ minutes 3) Although standard deviation of geometric mean method was smaller than anterior count method, gastric emptying curves from both method were similar. In daily practice, anterior count method may be useful alternative to geometric mean method in evaluation of gastric emptying rate.

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Bioequivalence Assessment of Nabumetone Tablets in Healthy Korean Volunteers

  • Park, Moon-Hee;Shin, In-Chul
    • Biomolecules & Therapeutics
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    • v.15 no.2
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    • pp.118-122
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    • 2007
  • This study was performed to evaluate the bioequivalency between the Osmetone$^{TM}$ Tablet (Myeongmoon Pharm. Co., Ltd.) as a test formulation and the Relafen$^{TM}$ Tablet (Handok Pharm. Co., Ltd.) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with Ultra-Violet (UV) detector. AUC$_t$, C$_{max}$ and T$_{max}$ were obtained from the time-plasma concentration curves, and log-transformed AUC$_t$ and C$_{max}$ and log-untransformed T$_{max}$ values for two formulations were compared by statistical tests and analysis of variation. AUC$_t$ was determined to be 897.8${\pm}$431.1 ug.hr/ml for the reference formulation and 902.3${\pm}$408.4 ug.hr/ml for the test formulation. The mean values of C$_{max}$ for the reference and test formulations were 24.2${\pm}$8.9 and 24.0${\pm}$9.5 ug/ml, respectively. The AUC$_t$ and C$_{max}$ ratios of the reference Relafen$^{TM}$ Tablet to the test Osmetone$^{TM}$ Tablet were +5.01% and -0.83%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for logtransformed AUC$_t$ and C$_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for AUC$_t$ and C$_{max}$ were located in ranges from log 0.80 to log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The Osmetone$^{TM}$ Tablet as the test formulation was considered to be bioequivalant to the Relafen$^{TM}$ Tablet used as its reference formulation, based on AUC$_t$ and C$_{max}$ values.